Amarin Corp Plc (AMRN)

[ziploc_1]

ROSE...The API shipped to the U.S. from abroad is processed here in the U.S....The manufacturing facilities in the U.S. must pass inspection to be certified by the FDA... and, occasionally these manufacturing facilities are not approved of by the FDA for one reason or another.

It is curious that the FDA says that the generics are "similar" to Vascepa...even though the generics lack the patented Vascepa encapsulation, which prevents the oxidization of the EPA in the Amarin branded Vascepa...despite the fact that the lack oxidation of the EPA is a very important element in the efficacy in Vascepa's reduction of CVD.

Why has the FDA chosen to ignore this important factor, which distinguishes Vascepa from generics??